Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 1935 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND Major Depressive Disorder

Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00905424
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : July 14, 2011
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Antidepressant + SPD489 (lisdexamfetamine dimesylate)
Drug: Antidepressant + placebo
Enrollment 246
Recruitment Details  
Pre-assignment Details 246 subjects entered the antidepressant lead-in phase receiving escitalopram oxalate (antidepressant) 20 mg/day for 8 weeks. After 8 weeks, subjects with residual depressive symptoms (n = 177) were randomly assigned (stratified by remission, either remitters or non-remitters) to receive augmentation therapy (either SPD489 or placebo).
Arm/Group Title Antidepressant + SPD489 Antidepressant + Placebo .
Hide Arm/Group Description Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline). Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
Period Title: Overall Study
Started 89 88
Completed 78 79
Not Completed 11 9
Reason Not Completed
Lost to Follow-up             3             3
Withdrawal by Subject             1             2
Adverse Event             4             2
Non-compliance with study medication             2             0
Sponsor decision             1             0
Positive urine drug screen             0             1
Non-adherence to visit schedule             0             1
Arm/Group Title Antidepressant + SPD489 Antidepressant + Placebo . Total
Hide Arm/Group Description Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline). Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters. Total of all reporting groups
Overall Number of Baseline Participants 88 85 173
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants 85 participants 173 participants
39.4  (9.65) 38.6  (10.38) 39.0  (9.99)
[1]
Measure Description: 177 subjects were randomized. However, 4 withdrew before receiving any randomized augmentation treatment. Therefore, 173 subjects were included in the Randomized Safety Analysis Set defined as all subjects who took at least 1 dose of randomized augmentation treatment and at least 1 follow-up safety assessment.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 88 participants 85 participants 173 participants
18-40 years 44 49 93
41-55 years 44 36 80
[1]
Measure Description: 177 subjects were randomized. However, 4 withdrew before receiving any randomized augmentation treatment. Therefore, 173 subjects were included in the Randomized Safety Analysis Set defined as all subjects who took at least 1 dose of randomized augmentation treatment and at least 1 follow-up safety assessment.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants 85 participants 173 participants
Female
53
  60.2%
54
  63.5%
107
  61.8%
Male
35
  39.8%
31
  36.5%
66
  38.2%
[1]
Measure Description: 177 subjects were randomized. However, 4 withdrew before receiving any randomized augmentation treatment. Therefore, 173 subjects were included in the Randomized Safety Analysis Set defined as all subjects who took at least 1 dose of randomized augmentation treatment and at least 1 follow-up safety assessment.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 88 participants 85 participants 173 participants
88 85 173
[1]
Measure Description: 177 subjects were randomized. However, 4 withdrew before receiving any randomized augmentation treatment. Therefore, 173 subjects were included in the Randomized Safety Analysis Set defined as all subjects who took at least 1 dose of randomized augmentation treatment and at least 1 follow-up safety assessment.
1.Primary Outcome
Title Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)
Hide Description MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Time Frame Augmentation Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Analysis Set defined as all non-remitters (MADRS total score greater than 10 at augmentation baseline) who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.
Arm/Group Title Antidepressant + SPD489 (Non-remitters) Antidepressant + Placebo (Non-remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 65 64
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-7.1  (0.93) -4.9  (0.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Non-remitters), Antidepressant + Placebo (Non-remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0902
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.3
Confidence Interval (2-Sided) 90%
-4.5 to -0.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF
Hide Description The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.
Time Frame Augmentation Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Analysis Set
Arm/Group Title Antidepressant + SPD489 (Non-remitters) Antidepressant + Placebo (Non-remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 65 64
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-4.9  (0.64) -4.0  (0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Non-remitters), Antidepressant + Placebo (Non-remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3091
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 90%
-2.4 to 0.6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6
Hide Description Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.
Time Frame Augmentation Baseline, 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Analysis Set
Arm/Group Title Antidepressant + SPD489 (Non-remitters) Antidepressant + Placebo (Non-remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 63 62
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.7  (0.73) -1.7  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Non-remitters), Antidepressant + Placebo (Non-remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0573
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.0
Confidence Interval (2-Sided) 90%
-3.7 to -0.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF
Hide Description Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Analysis Set
Arm/Group Title Antidepressant + SPD489 (Non-remitters) Antidepressant + Placebo (Non-remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 65 64
Measure Type: Number
Unit of Measure: Percent of Participants
60.0 45.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Non-remitters), Antidepressant + Placebo (Non-remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2368
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline
Hide Description CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time Frame Augmentation baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Analysis Set
Arm/Group Title Antidepressant + SPD489 (Non-remitters) Antidepressant + Placebo (Non-remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 64 64
Measure Type: Number
Unit of Measure: Percent of participants
Normal, not at all ill 1.5 1.6
Borderline mentally ill 20.0 12.5
Mildly ill 40.0 34.4
Moderately ill 32.3 48.4
Markedly ill 6.2 3.1
Severely ill 0 0
Among the most extremely ill 0 0
6.Secondary Outcome
Title Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6
Hide Description CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Analysis Set
Arm/Group Title Antidepressant + SPD489 (Non-remitters) Antidepressant + Placebo (Non-remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Unit of Measure: Percent of participants
Normal, not at all ill 27.0 14.5
Borderline mentally ill 31.7 24.2
Mildly ill 30.2 22.6
Moderately ill 9.5 29.0
Markedly ill 1.6 9.7
Severely ill 0 0
Among the most extremely ill 0 0
7.Secondary Outcome
Title Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6
Hide Description BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning.
Time Frame Augmentation Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Analysis Set
Arm/Group Title Antidepressant + SPD489 (Non-remitters) Antidepressant + Placebo (Non-remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 62 60
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Global Executive Composite -4.7  (1.03) -1.7  (1.04)
Behavioral Regulation Index -3.7  (0.97) -1.7  (0.99)
Metacognition Index -4.8  (1.04) -1.5  (1.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Non-remitters), Antidepressant + Placebo (Non-remitters)
Comments Global Executive Composite
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0463
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.0
Confidence Interval (2-Sided) 90%
-5.4 to -0.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Non-remitters), Antidepressant + Placebo (Non-remitters)
Comments Behavioral Regulation Index
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1431
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.0
Confidence Interval (2-Sided) 90%
-4.3 to 0.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Non-remitters), Antidepressant + Placebo (Non-remitters)
Comments Metacognition Index
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0281
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.3
Confidence Interval (2-Sided) 90%
-5.8 to -0.8
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6
Hide Description MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.
Time Frame Augmentation Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Analysis Set
Arm/Group Title Antidepressant + SPD489 (Non-remitters) Antidepressant + Placebo (Non-remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 63 62
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-5.3  (1.25) -2.3  (1.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Non-remitters), Antidepressant + Placebo (Non-remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0920
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.0
Confidence Interval (2-Sided) 90%
-6.0 to -0.1
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6
Hide Description QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.
Time Frame Augmentation Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Analysis Set
Arm/Group Title Antidepressant + SPD489 (Non-remitters) Antidepressant + Placebo (Non-remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 63 62
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.4  (0.45) -1.2  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Non-remitters), Antidepressant + Placebo (Non-remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0774
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 90%
-2.2 to -0.1
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF
Hide Description MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Time Frame Augmentation Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) defined as all subjects who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.
Arm/Group Title Antidepressant + SPD489 (Remitters) Antidepressant + Placebo (Remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 23 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.1  (1.13) -1.1  (1.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Remitters), Antidepressant + Placebo (Remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4726
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (2-Sided) 90%
-1.6 to 4.0
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF
Hide Description The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.
Time Frame Augmentation Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Antidepressant + SPD489 (Remitters) Antidepressant + Placebo (Remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 23 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.8  (0.92) -1.6  (0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Remitters), Antidepressant + Placebo (Remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5182
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.9
Confidence Interval (2-Sided) 90%
-1.4 to 3.1
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6
Hide Description Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.
Time Frame Augmentation Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Antidepressant + SPD489 (Remitters) Antidepressant + Placebo (Remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 22 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.6  (0.89) -0.6  (0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Remitters), Antidepressant + Placebo (Remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4630
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 90%
-3.1 to 1.2
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF
Hide Description Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Antidepressant + SPD489 (Remitters) Antidepressant + Placebo (Remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: Percent of participants
65.2 52.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Remitters), Antidepressant + Placebo (Remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5230
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
14.Secondary Outcome
Title Assessment in Remitters of CGI-S at Augmentation Baseline
Hide Description CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time Frame Augmentation Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Antidepressant + SPD489 (Remitters) Antidepressant + Placebo (Remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 23 21
Measure Type: Number
Unit of Measure: Percent of participants
Normal, not at all ill 26.1 23.8
Borderline mentally ill 47.8 71.4
Mildly ill 21.7 4.8
Moderately ill 4.3 0
Markedly ill 0 0
Severely ill 0 0
Among the most extremely ill 0 0
15.Secondary Outcome
Title Assessment in Remitters of CGI-S at Week 6
Hide Description CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Antidepressant + SPD489 (Remitters) Antidepressant + Placebo (Remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: Percent of participants
Normal, not at all ill 50.0 61.9
Borderline mentally ill 36.4 23.8
Mildly ill 13.6 9.5
Moderately ill 0 4.8
Markedly ill 0 0
Severely ill 0 0
Among the most extremely ill 0 0
16.Secondary Outcome
Title Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6
Hide Description BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.
Time Frame Augmentation baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Antidepressant + SPD489 (Remitters) Antidepressant + Placebo (Remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 21 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Global Executive Composite -0.9  (1.21) -2.7  (1.21)
Behavioral Regulation Index -0.4  (1.37) -1.5  (1.37)
Metacognition Index -1.1  (1.24) -3.4  (1.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Remitters), Antidepressant + Placebo (Remitters)
Comments Global Executive Composite
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2876
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.8
Confidence Interval (2-Sided) 90%
-1.0 to 4.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Remitters), Antidepressant + Placebo (Remitters)
Comments Behavioral Regulation Index
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5590
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.1
Confidence Interval (2-Sided) 90%
-2.1 to 4.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Remitters), Antidepressant + Placebo (Remitters)
Comments Metacognition Index
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2079
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.3
Confidence Interval (2-Sided) 90%
-0.7 to 5.2
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6
Hide Description MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.
Time Frame Augmentation baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Antidepressant + SPD489 (Remitters) Antidepressant + Placebo (Remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 22 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-4.0  (1.77) -0.2  (1.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Remitters), Antidepressant + Placebo (Remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1489
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.7
Confidence Interval (2-Sided) 90%
-8.0 to 0.5
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6
Hide Description QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.
Time Frame Augmentation baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Antidepressant + SPD489 (Remitters) Antidepressant + Placebo (Remitters)
Hide Arm/Group Description:
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
Overall Number of Participants Analyzed 22 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-1.9  (0.57) -0.4  (0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Antidepressant + SPD489 (Remitters), Antidepressant + Placebo (Remitters)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0852
Comments The test was performed a priori at the significance level of 0.10
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.4
Confidence Interval (2-Sided) 90%
-2.8 to -0.1
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Randomized Safety Analysis Set (RSAS) defined as all subjects who take at least 1 dose of randomized augmentation treatment and at least 1 follow-up safety assessment.
 
Arm/Group Title Antidepressant + SPD489 Antidepressant + Placebo .
Hide Arm/Group Description Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline). Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
All-Cause Mortality
Antidepressant + SPD489 Antidepressant + Placebo .
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Antidepressant + SPD489 Antidepressant + Placebo .
Affected / at Risk (%) Affected / at Risk (%)
Total   0/88 (0.00%)   1/85 (1.18%) 
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis  0/88 (0.00%)  1/85 (1.18%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Antidepressant + SPD489 Antidepressant + Placebo .
Affected / at Risk (%) Affected / at Risk (%)
Total   35/88 (39.77%)   15/85 (17.65%) 
Gastrointestinal disorders     
Dry mouth  10/88 (11.36%)  0/85 (0.00%) 
Infections and infestations     
Nasopharyngitis  5/88 (5.68%)  3/85 (3.53%) 
Metabolism and nutrition disorders     
Decreased appetite  6/88 (6.82%)  2/85 (2.35%) 
Nervous system disorders     
Headache  10/88 (11.36%)  4/85 (4.71%) 
Psychiatric disorders     
Insomnia  4/88 (4.55%)  6/85 (7.06%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Timothy Whittaker, M.D.
Organization: Shire Pharmaceuticals, Ltd.
EMail: twhitaker@shire.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00905424     History of Changes
Other Study ID Numbers: SPD489-203
First Submitted: May 18, 2009
First Posted: May 20, 2009
Results First Submitted: June 15, 2011
Results First Posted: July 14, 2011
Last Update Posted: September 9, 2013